A triumph of the heart

A mechanical device keeps a baby alive until her transplant.

ST. PETERSBURG - When Alyssa Thomas' tiny heart failed three months ago, a piece of German machinery kicked in.

Called a Berlin Heart, the device kept Alyssa alive for 75 days until she received a new donor heart.

Alyssa is just the second child in Florida to use the Berlin Heart, which is not yet approved by the Food and Drug Administration.

The device - which pumps blood for the heart - has been used fewer than 100 times in the United States since it was first introduced in 2000.

Doctors at All Children's Hospital in St. Petersburg showed off their success Monday.

The 19-month-old Alyssa bobbed on her father's lap and stared at the faces in the crowd only weeks after her heart transplant.

Alyssa was "about as close to dying as possible," said Dr. Jeff Jacobs, a pediatric cardiovascular surgeon who attached the temporary Berlin Heart and then Alyssa's new heart.

"To come through it all and be where we are now, it's truly amazing," he said.

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For her first 15 months, Alyssa showed no symptoms of a weak heart.

Her mother, a registered nurse from Orlando, took Alyssa to the Arnold Palmer Hospital for Children on Jan. 31 after she could not stop vomiting.

There, her heart stopped beating.

Doctors took 52 minutes to resuscitate the infant. Later, they realized her own immune system had been attacking her heart.

The uncommon disorder, called myocarditis, can be the body's response to something as simple as a common cold, doctors said.

But without a treatment, and with Alyssa's left ventricle failing, doctors needed a new heart. On Feb. 2, she was moved to All Children's.

Doctors there put her on a machine called an ECMO. Extracorporeal Membrane Oxygenation does the work of a heart, but patients must be sedated. And using the machine for more than two weeks could cause life-threatening side effects.

Unable to use medicine to stabilize the heart, doctors at All Children's searched for an alternative to save her life.

The Berlin Heart

The Berlin Heart has been used on 285 children worldwide, ranging from 4-pound newborns to 200-pound teens, according to the German manufacturer of the same name.

Unlike a similar device for adults, the pump sits on the chest outside the body.

The Berlin Heart takes the place of a ventricle, pumping blood to the aorta and throughout the body. The Food and Drug Administration is just beginning to study the device.

Dr. Alfred Asante-Korang, a pediatric cardiologist at All Children's, said Jacobs applied to the hospital and then the FDA to perform the procedure. Special cases like Alyssa's can receive an exemption from FDA rules when no other treatment is available, Asante-Korang said.

Once the FDA and the hospital signed off, specialized medical technicians flew in from Germany with the $100,000 device.

Alyssa's surgery, on the afternoon of Feb. 12, took seven hours.

Waiting for transplant

Alyssa's new donor heart took its first beat about 10:30 a.m. April 28, her family said. Officials would not release any details about where the heart came from.

Without the assistance of the Berlin Heart, she would have likely died waiting, doctors said.

In 2005, there were 192 heart transplants performed on children 10 and younger, according to the United Network for Organ Sharing.

But most of those children need medicine, not a device like the Berlin Heart, to stay alive, Jacobs said.

Alyssa, it turned out, had a rare disorder that triggered a form of heart failure that needed a different solution.

The cost of Alyssa's treatment already exceeds more than $1-million, officials said. At least some of it will be covered by All Children's and Orlando Regional Healthcare, where Alyssa's mother works, said All Children's chief executive Gary Carnes.

After a stroke, a broken heart, a three-month wait for a new one, and worries about brain damage, Alyssa's family left the hospital Monday to continue the healing process.

Doctors would not predict what would happen next. But Jacobs, a surgeon, said that they have come this far is already amazing.

"It's not always a success like this," he said. "It did border on a miracle to think where she was two months ago, and where she is now."